This invention relates generally to devices for collecting and preserving specimens of biological fluid for use as evidence, and particularly to an apparatus and method of using that apparatus for collecting urine specimens and supplying those specimens to a remote laboratory facility for analytical testing.
In recent years, several factors have brought the procedures and practices used for collecting and preserving biological samples into closer inspection. The increase in efforts to inform the public concerning the many dangers of addictive and perception altering drugs, and to stop their widespread usage, is one major force which has fostered this awareness.
Expensive promotional campaigns on television and other media regarding such problems as cocaine and driving while intoxicated have increased public awareness of the personal and public dangers of such drugs, and heightened the public's intolerance to the use of such chemicals when the harm or danger is not merely to the user, but to the public as well.
Increased liability by private companies and public carriers for the negligence and recklessness of its employees, and the opening of widespread drug testing of federal employees, have paved the way towards significantly increased drug testing programs for private sector employees.
Urinalysis has been selected as one preferred vehicle for chemical testing, since it may be performed under the direction and supervision of personnel having no medical training, entails the least intrusion to the body of the person being tested, and the process of sample collection may be performed quickly and inexpensively in the workplace.
Urinalysis has also become an important factor in testing for drivers who are or may be under the influence of a drug or intoxicating liquor. While blood testing is generally considered the most accurate and convincing evidence by the courts, some states permit or require that persons be given the choice between blood and urine testing, on the basis of minimizing the invasion to the persons or their privacy.
The results of employee drug testing programs can often be catastrophic for an individual's career and reputation. The mere assertion that the results of an unspecified drug test were positive can completely undermine the respect and confidence of an employer or fellow employees, and subject the employee to sanctions, embarrassment, suspicion, and permanently taint their records. A positive drug test, even if the results were not due to the presence and detection of overt amounts of illicit or controlled substances, can result in termination and a continuing plague of problems.
The results of even the most modern drug tests may be affected by many harmless precursors, other prescription and non-prescription drugs. The tests themselves may also be attacked on a chain of custody theory in much the same manner as criminal evidence.
Employers, subject to the backlash of legal consequences for improper testing and the harms and damages which unfounded accusations could produce, have created a vested interest in employers and those performing routine drug testing to ensure the accuracy and reliability of those tests, and to similarly guarantee that the testing equipment will not be tampered with or questioned.
The public, particularly individuals who must submit to drug testing as a prerequisite for their employment and who are not drug users or abusers, have a vested interest in accurate testing and in ensuring that the testing methods are as free from possible intentional tampering or human error as they can be.
Law enforcement officials and investigators similarly want drug testing to be as accurate, reliable, and provable as possible so that the results will stand up in court or an administrative hearing. The public's interest in those cases where a positive drug test will lead to identifying an individual who has a chemical abuse problem, to ensure that person is prevented from jeopardizing the lives of others and receives the needed therapy and assistance, must also be considered.
Drug testing procedures currently in use generally require that a vial or specimen container be provided to the personnel supervising the testing, that the individual to be tested provide a sample of biological fluid, and that sample be forwarded to a laboratory facility for analytical testing.
While the currently employed methods vary depending upon the testing authority and the equipment provided, there are several common drawbacks to each method which have been identified.
Primarily, while the samples may sometimes be sealed in specimen containers once they have been obtained from the individual being tested, it cannot be verified that the equipment and containers being used for the testing were not tampered with, or were free of contaminants, prior to the testing. Similarly, the chain of custody prior to testing cannot be verified.
The testing equipment usually provides an ineffective seal for the specimen container, and only one seal when such is provided. The seal may frequently be neglected or omitted by the person supervising the testing. The person being tested often does not have an opportunity to inspect the testing equipment, an important factor to consider for purposes of belaying the apprehensions of the person being testing, or as a means of additional verification of the testing procedures. While a supervising person may be instructed in the proper testing and control procedures, there is always a chance of human error or the possibility that the supervisors will not understand the legal significance of the various steps of the process, and so the steps should be made as uniform, as often repeated, and as automatic as possible.
Tamper evident seals for plastic containers, such as those used in food packaging, are well known, a representative example being given by U.S. Pat. No. 4,087,018. Additional devices for securing a fluid container and evidencing tampering are known, such as those sealing closures disclosed in U.S. Pat. Nos. 1,996,682 and 4,262,814 and the related art. Another sealed container disposed within a second sealed package is disclosed in U.S. Pat. No. 985,850.
Each of these patents, while being representative of a broad field of art and disclosing a method of identifying or evidencing whether a container has been tampered with, each prove to have one or more defects making them unsuitable for application to the process of collecting a fluid biological sample for use as evidence.
Those containers in which an item or product is sealed so as to evidence tampering already contain the item to be protected. There is no provision for the container to exist in a tamper evidencing state prior to the product being placed therein, or for resealing the tamper evidencing closure once the item has been placed in the container. Similarly, there is no apparatus which automatically creates a new tamper evident seal when the container is closed once the original seal is broken, nor that enhances or facilitates verifying the chain of custody of the container. U.S. Pat. No. 4,362,698 discloses a permanently sealed laboratory vessel used in blood testing, however the manner of providing the closure to this vessel is unsuitable for use in the collection of biological samples in the field, or for preserving those samples during transportation to the testing facility.